BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA SET W/INJECTOR

    MDR report key: 2152196 · Received June 23, 2011

    Report

    Report Number
    9613251-2011-00128
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 24, 2011
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE PROTECTIVE COVER WAS MISSING FROM THE PCA INJECTOR TUBING SET, SUBSEQUENTLY, THE HEALTHCARE PROFESSIONAL RECEIVED A NEEDLE STICK. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL REACHED INTO A STORAGE BIN AND GRASPED THE PCA INJECTOR TUBING SET. AT THAT TIME, HEALTHCARE PROFESSIONAL WAS STUCK IN THE FINGER BY THE NEEDLE TIP OF THE PCA SYRINGE BARREL ASSEMBLY THAT HAD PUNCTURED THE PACKAGE. IT WAS REPORTED THAT THE PROTECTIVE COVER ON THE END OF THE PCA SYRINGE BARREL ASSEMBLY WAS MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE HEALTHCARE PROFESSIONAL AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. HOSPIRA IS CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA SET W/INJECTOR 80MEA MEA HOSPIRA, LTD. NA 941614W

    Patients

    Seq Age Sex Outcome Treatment
    1